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TABLE OF CONTENTS>I Introduction to AccreditationIIIIIIVForeword: Message from COLA CEO . . . . . . . . . . . . . . . . . . 1-1COLA Accreditation – An Introduction and Overview . . . 1-2Laboratories Eligible for COLA Accreditation . . . . . . . . . . . 1-2The VALUE of COLA Accreditation . . . . . . . . . . . . . . . . . . . . 1-3Here’s How to Contact COLA and Get Help Fast . . . . . . . . 1-4COLA, Regulatory Compliance, and Your Laboratory . . . . 1-5COLA Accreditation: How It Works, What to DoThe Road to Accreditation:Important Facts You Need to Know . . . . . . . . . . . . . . . . . . 2-3Step 1: Enrollment and Completion of Forms . . . . . . . . . . 2-6Step 2: Completing the Self-Assessment . . . . . . . . . . . . . . 2-7Step 3: On-site Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8Step 4: Post-Survey and Corrective Action . . . . . . . . . . . 2-12Step 5: Accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15COLA Criteria for Quality Laboratory PerformanceOverview: COLA Criteria for Quality LaboratoryPerformance and Self Assessment Questions . . . . . . . . . . 3-2The Criteria and Self-AssessmentFollow the Path of Workflow . . . . . . . . . . . . . . . . . . . . . . . . 3-2About the Self-Assessment Questionsand Answer Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3Essential (E) vs. Required (R) Criteria . . . . . . . . . . . . . . . . . . 3-3The Criteria Cover 14 Main Evaluation Groupingsin the Laboratory Path of Workflow . . . . . . . . . . . . . . . . . . 3-4Understanding the Criteria and Completingthe Self-Assessment: Helpful Informationby Evaluation Grouping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5Additional Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-94Educational Resources and SupportCOLA’s LabUniversity ® On-Line Continuing Education . . . 4-1Educational Publications and Information Sheets . . . . . . 4-2Additional COLA ProgramsCOLA’s Quality Management Systems Accreditation . . . . 4-2Symposium for Clinical Laboratories . . . . . . . . . . . . . . . . 4-2COLA’s Laboratory Director Program for Physicians . . . . . 4-3Other Internet Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3Accreditation Quick Look:What’s InvolvedYou complete a series of steps on yourroad to accreditation:INFORMATION GATHERINGAND REPORTING…• Upfront, you supply COLA withinformation about your laboratory• You become familiar with the steps inaccreditation and responsibilities in theprocess• You conduct a detailed self-assessmentof your laboratory operations, reportingthe data to COLA• You make sure you meet otherrequirements of state and federalagencies• You have your proficiency testing datareleased to COLA and respond tonotices of unsuccessful performanceON-SITE SURVEY…• COLA conducts an on-site survey toassess your laboratory’s complianceFEEDBACK AND IMPROVEMENT…• COLA experts provide you withfeedback on your laboratory’s operation,including identification ofnoncompliances that need to becorrected• COLA experts provide you withexperienced guidance in thecorrection of noncompliant criteria• Your laboratory addresses areas ofnoncompliance and takes correctiveaction• You provide documented proofof improvements to COLACONGRATULATIONS! ACCREDITATION…• When COLA has determined that youare compliant with all of its criteria,your laboratory is granted accreditationV Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .© 2007 COLA FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org3